Japanese Electronic Medicinal Product Information (ePI-JP), published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-jp/ and changes regularly. See the Directory of published versions
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Official URL: http://hl7.org/fhir/uv/epi-jp-ig/ImplementationGuide/hl7.fhir.uv.epi-jp-ig
The Electronic Product Information (ePI) Japan Implementation Guide (IG) provides a standardized framework to support the transition from the custom XML-based package insert format of the Pharmaceuticals and Medical Devices Agency (PMDA) to the FHIR (Fast Healthcare Interoperability Resources) ePI standard. This IG is designed to ensure that the structure, content, and regulatory requirements of Japanese pharmaceutical package inserts are fully preserved in the FHIR-based ePI format.
PMDA's current XML schema (defined in package_insert-XML.xsd and package_insert-XML-Transitional.xsd) supports detailed package insert information with specific section headings, metadata, and formatting rules tailored to Japan-specific regulatory needs. The accompanying XSL transformation files (preview.xsl, preview_ja.xsl, preview_en.xsl) and CSS (preview.css) define the display format for these documents. This IG leverages these existing structures by mapping PMDA XML elements to FHIR resources (such as Bundle and Composition), ensuring continuity in content organization, regulatory compliance, and visual representation.
The ePI Japan IG complies with the FHIR ePI standard, enabling interoperability within Japan's healthcare system. It also addresses Japan-specific requirements (such as multilingual support for Japanese and English, section-specific styles for contraindications and warnings, and metadata for revision tracking). By adopting FHIR, this IG aims to improve the accessibility, machine-readability, and integration of package insert data in Japan's healthcare system.
Scope
The scope of this implementation guide is as follows:
Mapping from PMDA XML to FHIR ePI: Defines methods to represent elements of the PMDA XML schema (e.g., sections like HDR_IndicationsOrEfficacy, HDR_ContraIndications) using FHIR resources (such as Bundle and Composition).
Preservation of Japanese Package Insert Templates: Fully supports Japanese package insert templates (e.g., section headings like Indications or Effects, Contraindications), metadata (e.g., revision symbols), and formatting (e.g., red borders for contraindications) in FHIR ePI output.
Multilingual Support: Accommodates Japanese and English package insert content as specified in preview_ja.xsl and preview_en.xsl to meet regulatory and user needs.
Regulatory Compliance: Adheres to PMDA's metadata rules for revision tracking (e.g., revisionPrev-editor, revisionThis-editor) to ensure regulatory information is accurately represented in FHIR.
Interoperability: Enables integration with Japan's healthcare system through FHIR, supporting use cases such as pharmacovigilance and clinical decision support within Japan.
Tools and Validation: Provides guidance on tools, profiles, and validation processes for converting PMDA XML to FHIR ePI and validating the resulting FHIR resources against this IG.
This IG does not apply to PMDA's regulatory processes, approval workflows, or changes to package insert content. These remain under PMDA's jurisdiction.
Purpose
The purposes of the ePI Japan Implementation Guide are as follows:
Facilitate Transition to FHIR ePI: Provides clear mappings and examples for converting PMDA XML-based package inserts to FHIR ePI, minimizing impact on existing workflows.
Maintain Japan-Specific Requirements: Ensures that Japanese package insert templates (section headings, styles (e.g., defined in preview.css), metadata, etc.) are preserved in FHIR representations.
Improve Interoperability: Enables sharing and integration of package insert data within Japan's healthcare system through FHIR, supporting use cases such as pharmacovigilance and clinical decision support.
Support Multilingual Accessibility: Ensures that Japanese and English package inserts are accurately represented and styled according to preview_ja.xsl and preview_en.xsl.
Promote Machine-Readability: Builds structured package insert data in FHIR resources to enable automated processing, searchability, and analysis, improving usability for Japanese healthcare professionals and systems.
Provide Implementation Guidance: Offers detailed profiles, examples, and validation tools to support implementers adopting the FHIR ePI standard for Japanese package inserts.
Supplementary Notes
Alignment with PMDA Standards: This IG respects PMDA's XML structures (e.g., special tables like ContraIndication_table, CompositionAndProperty_table) and styles (e.g., red borders for warnings, specific font families). These are mapped to FHIR resources using appropriate extensions to maintain fidelity.
Revision Tracking: PMDA XML includes revision symbols for tracking changes (e.g., revisionPrevThis-editor). This IG defines how such metadata is captured in FHIR (e.g., using extensions or annotations).
Styles and Display: The preview.css file specifies detailed styles such as margins, fonts, and borders. This IG provides guidance on preserving these in FHIR ePI (e.g., via CSS or narrative text in Composition resources).
Future Extensibility: While focused on the current PMDA XML schema, this IG is designed to be extensible to accommodate future updates to PMDA requirements or the FHIR ePI standard.
For details, please refer to the FHIR ePI specifications and PMDA package insert guidelines. Contributions and feedback are welcome on the GitHub repository.